Two infiltrations of the recess as well as the lateral sacral margin with crystalline corticosteroid and local anesthetic using imaging (X-ray, CT) documented

Two infiltrations of the joint with X-ray or CT monitoring using contrast agent as well as Triam or Volon 40/bupivacaine, verified with print-outs or DICOM files

Patients must respond with a significant pain reduction of >50% to either the infiltration of the recess or lateral sacrum margin or to injection of the joint; two groups may possibly be resolved here depending on the response to the different injection sites

The questionnaires of standard scores need to be adapted to SIJ specifications:

ODI

McGill

SF12

MVAS

Roland-Morris

patient satisfaction

depression status

individual score (NEW: "That's MY problem")

pain diagram

Above proposals can be discussed in the conception of clinical trials for sij fusion. Supplemental concepts for non surgical comparative studies must be worked out as well.

Literature shows very few clinical SIJ fusion trials until 2012. There seems to be a lack of common sense within the medical community about the pain generator and appropriate therapies – particularly for preoperated and chronic pain patients. Therefore a standardized study protocol has not yet be developed.

Randomized comparative studies of surgical methods are required. Premise: availability of a reference procedure. Medical device industry initiated some single-arm studies (single- or multicentered), and also some randomized studies have been started using non surgical therapies as a 2nd arm. The following overview was taken from clinicaltrials.gov as well as publically available information (no responsibility is taken for the correctness of this information):

Some of the information below was provided by the MD manufacturers, latest update 2014/03. An update on this is to be expected after the ICSJS 2018 in February 2018.

SIJ-Fusion with Ifuse Implant System (SIFI); The purpose of this study is to evaluate the use of the iFuse Implant System to treat degenerative sacroiliitis (arthritis of the SI joint) and sacroiliac disruption (abnormal separation or tearing of the sacroiliac joint).

Primary Outcome Measures: The change in lower back pain as rated by the study subject using a 0-100 visual analog scale (VAS) at 6 months after initiation of treatment

Secondary Outcome Measures: Change from baseline in lower back pain (VAS) and leg pain (VAS, in disability due to back pain (ODI), in quality of life (EQ-5D), in ambulatory and work status, in depression score (Zung Depression Scale), Change in objective functional test (ASLR),

The purpose of this study is to evaluate the long term safety and effectiveness of SI joint fusion using the iFuse Implant System in patients with degenerative sacroiliitis (DS) and/or sacroiliac joint disruptions (SD).

Study Design: This study is extended follow-up from two ongoing multicenter prospective US clinical trials. All participants have already undergone the surgical procedure of interest (SI joint fusion with iFuse Implant System).

Trial 1

prospective, non-randomized, single center study to collect data on fusion and pain reduction following implantation of the SImmetry device. Up to 15 total subjects will be implanted and followed for 24 months. Data will be collected pre-operatively, at implant, discharge, and at specified follow-up time points (6 weeks, 3 months, 6 months, 12 months, 24 months.)

Outcome:

intraarticular fusion, pain reduction

Trial 2

prospective, non-randomized post market study designed to collect data on SI joint fusion and subject back pain following implant of the SImmetry device.

Outcome:

SIJ Fusion: Confirmed fusion of the SI joint at 12 and 24 months, defined as presence of a continuous segment of solid bridging bone that extends from the sacrum to the ilium; SIJ Pain Reduction: evaluated by use of Visual Analogue Scale (VAS) for back pain for comparison of baseline to 12 and 24 months

The objective of this study is to gather clinical data on SI-LOK® for the treatment of sacroiliac joint dysfunction. The purpose of this prospective study is to evaluate clinical and radiographic outcomes, intra-operative parameters, patient satisfaction and work status following a procedure using SI-LOK® for treatment of sacroiliac joint dysfunction with a minimum of three screws.